Lemborexant has potential for sustained insomnia improvement for midlife women

Key takeaways:

• Lemborexant 10 mg improved subjective sleep-onset latency for midlife women with insomnia at 6 months.
• Most reported treatment-emergent adverse events were mild to moderate in severity.

Lemborexant resulted in sustained improvement in sleep parameters at 12 months among midlife women with insomnia and might be a treatment option for this patient population, researchers reported in Menopause.

Lemborexant, a competitive dual orexin receptor antagonist, was approved by the FDA in 2019 to treat adults with insomnia through reducing wakefulness by attenuating orexin-mediated wake drive.

“This additional treatment option is particularly important in primary care, as insomnia is an important concern and may be underestimated in this setting,” Masakazu Terauchi, MD, PhD, NCMP, from the department of women’s health at the Tokyo Medical and Dental University, Tokyo, and colleagues wrote. “A post-hoc analysis of the pivotal Study 303 was conducted to examine patient-reported efficacy and safety for up to 12 months in midlife women.”

Terauchi and colleagues conducted a post-hoc analysis of the Study 303 SUNRISE-2, which was a randomized, double-blind, placebo-controlled trial with 949 adults with insomnia. During the first 6 months, participants received lemborexant 5 mg or 10 mg or placebo. During the last 6 months, participants who received lemborexant continued their treatment dose, and participants on placebo switched to either lemborexant 5 mg or 10 mg. Of the full study participants, 280 were midlife women. Of these, 28.3% were randomized to the placebo group, 25.9% were randomized to lemborexant 5 mg and 34.3% were randomized to lemborexant 10 mg.

At 6 months, researchers observed a statistically significantly greater median change in subjective sleep-onset latency of –30.4 minutes for the lemborexant 10-mg group (P = .031). Changes in subjective sleep-onset latency with lemborexant 5-mg were not statistically significantly different from those with placebo. Changes in subjective wake after sleep onset also were not statistically significant. In addition, benefits in subjective wake after sleep onset were sustained through 12 months of the study, according to the researchers.

Researchers also noted greater Insomnia Severity Index total score and Fatigue Severity Scale total score improvements observed at 6 months among participants treated with lemborexant 5 mg (–9.8 and –9.9, respectively) and 10 mg (–10.7 and –9, respectively) and placebo (–8.3 and –7.4, respectively), with benefits continuing to 12 months of treatment, according to the researchers. However, only lemborexant 10 mg was associated with significant improvements for both scores at 6 and 12 months, according to the researchers.

Most reported treatment-emergent adverse events were mild to moderate in severity, and the most common reported in the lemborexant 5 mg and 10 mg groups were somnolence (1.6% and 1.3%, respectively), nasopharyngitis (14.1% and 9.2%, respectively) and headache (6.3% and 5.3%, respectively), according to the researchers.

“In conjunction with participant-reported reductions in insomnia and fatigue severity with [lemborexant], both critical factors associated with sleep disturbance in this patient population, these data suggest that [lemborexant] may be a potential treatment option for midlife women with insomnia,” the researchers wrote.